Medication compliance systems and associated medication dispensing devices, and their equivalents, are known in the prior art. These systems are used for overseeing and coordinating the administration of medication regimens. Present systems function primarily to remind the patients when to take a particular medication and to automatically dispense that medication in accordance with a prescription schedule. Integration of CPU-based microprocessors into the compliance, co-ordination and dispensing system hardware has allowed the most recent systems to handle even more complex regimens, often involving multiple medications and administration criteria. These systems are particularly directed to coordinating and administering a complex medication regimen at home, outside the support of a hospital or pharmacy.
Critical to the effectiveness of a compliance, co-ordination and dispensing system is a method of assuring the care-giver that a patient is complying with the administration regimen. Moreover, the medication compliance and dispensing system should provide some protection from overdosage and underdosage. Generally speaking, prior art compliance and dispensing systems are able to regulate dosage and frequency according to administration criteria stored in the internal memory of the device's control sub-system. These devices can often provide a record of the administration history, which a care-giver can later review for patient compliance or non-compliance. Some medical dispensers provide protection by restricting patient access to medication only in accordance with a prescription schedule.
As the health care industry continues to change, the importance of self-administered medication regimens will also continue to increase. This increase challenges the adequacy of existing compliance and dispensing systems in meeting the demands of a wider variety of patient needs and even more complex medication regimens.
It is now apparent that the compliance and dispensing systems in the prior art are limited in use by certain members of the patient populations, particularly those with special needs, such as children, the elderly, the visually-impaired, the hearing-impaired and patients with failing memory. With respect to these subpopulations, it is imperative to provide compliance, co-ordination and dispensing systems and medical dispensers which feature further assurances of compliance and greater protection from overdosage and underdosage. The increased popularity has also created a demand for compliance, co-ordination and dispensing systems which are more convenient to use and more conducive to the lifestyle of any type of patient.
Typical of present systems, U.S. Pat. No. 5,329,459, issued to Kaufman et al, and U.S. Pat. No. 5,159,581 issued to Agans, disclose an interactive medication dispenser capable of storing and dispensing a plurality of medication, reminding the patient of administration times, and discriminating between the different categories of medication stored, as well as the different schedules of medication administration. These prior art approaches include a housing for storage and dispensing of a plurality of medication on demand from a programmable control element integrated with the device. The CPU-based control element communicates with internal memory containing medication administration criteria, a medication delivery system and output devices which send audible or displayed messages to the patient or care-giver, including a speech output means, a visual display and other control signal devices.
The approach disclosed in U.S. Pat. No. 5,291,191, issued to Moore, is intended to improve access by the visually-impaired to such a medical dispenser. The Moore approach dispenses medication according to a prescription schedule. When a medication is dispensed, the device selectively broadcasts an audible description of the specified medication. The invention includes a housing, an saudible broadcast means, and switch means for regulating access to a predetermined storage compartment and causing a sound playback means to broadcast a message associated with that compartment.
Moore also teaches designing the cabinet of the housing such that the compartments slide downwardly from the closed position to an open position, and whereby gravity defines the urging means. When individual switches are closed or opened via a control system, in accordance with a prescribed schedule, access to the compartment containing the subject medication is allowed. When the compartment is actually opened, e.g. by the patient, another switch causes the control element to broadcast or display a specific message associated with that medication.
A first problem recognized in the above-described prior art is that the dispensing devices eject medication automatically according to a timed sequence or schedule, but do not provide assurances that the medication was taken, and, if taken, when the medication was taken. In this regard, the devices do not provide adequate protection against both underdosage and underdosage. If the patient fails to take the medication according to schedule, the system continues to dispense medication at set intervals under the false assumption or premise that the patient took previous medications accordingly. Such a situation greatly enhances the risk of underdosage--the patient takes less than is prescribed. An equally critical situation arises if the patient takes the medication not according to schedule, but long after it is dispensed. If the patient takes the medication too close to the time for taking the subsequent medication, the patient is in danger of overdosage.
An attempt to provide some of the protection and assurances lacking in the prior art is evidenced in U.S. Pat. No. 5,392,952 issued to Bowden. Bowden '952 is another medication dispensing system for providing specific doses of medication in accordance with a pre-determined schedule. The device is specifically targeted for use by the elderly, the visually-impaired, the hearing-impaired and the disabled, and for prevention of overdosage. The system provides information regarding the medication regimens of the patient and specific instructions associated with each medication, including dosage, whether to take with water or food, and whether it is necessary to refill any of the medication supplies. The Bowden system also monitors and records compliance, or non-compliance, by the patient, with the compliance information then made available to a care-giver for review.
As with the previous devices, the Bowden approach includes a plurality of compartments for storage and dispensing of medication and a control element for receiving and storing medication administration criteria, e.g. the time periods for dispensing medication and specific instructions associated with each medication. The control element also actuates the display and broadcast of messages to either the care-giver or the patient. In Bowden '952, overdose protection is provided by a mechanism and operation for retrieving pills which are delivered but not removed from the dispenser within a specified time period. The previously dispensed pills are restocked in the device's storage area.
One problem with Bowden '952, however, is that the prescribed medication can be dispensed on demand, thereby allowing the patient to continue to press a button for multiple dosage at the same time. This is especially a problem for a patient with limited manual dexterity. Such a patient is susceptible to inadvertently requesting multiple dosage at once, thereby interrupting and thus invalidating the prescription schedule. In addition, someone besides the patient could gain unrestricted access to the medications as well.
Another deficiency in Bowden '952, and common to present pill dispensing devices, is that the dispensing apparatus dispenses into a common drawer or tray. When multiple medications are dispensed, or when multiple medications have gathered in the tray, a patient is forced to discriminate between the pills, for example, when administering instructions differ between the pills. A visually-impaired patient finds this task difficult if not impossible. When the pills are identical in color, shape or form, as are many forms of medication, even a patient with some visual acuity will find the task just as challenging.
Although Bowden '952 is specifically directed at providing a compliance system and medical dispenser with improved protection from overdosage and some assurances of patient compliance, existing systems are still lacking.
However, the present invention, in contrast, provides a compliance, co-ordination and dispensing system embodying the desirable aspects of recent technology, but introduces new mechanisms and operations which provide additional assurances of patient compliance and greater protection from overdosage and underdosage. The improvements are necessary in order for these health care devices to effectively service the elderly, the visually-impaired, the hearing-impaired, the mentally ill, and others with handicaps.
Because of the increased complexity of medical regimens, it is also desirable for a compliance and dispensing system to provide more extensive and more accessible information on the medications and their administration. The Moore '191 and Bowden '952 devices give limited information regarding dosage, dosage times, how to take the medication and supply status to the patient.
However, the present invention preferably provides administering instructions, information on side effects, precautionary measures, symptoms to watch and when the patient should call a doctor. Moreover, such information is be accessible, in one form or other, to the variety of patients to which the present invention is directed. The present invention's compliance, co-ordination and dispensing system preferably also provide means for communicating the information to the care-giver, and to the patient when he/she is not in the vicinity of the device.
There is also a need to provide compliance systems which are more convenient to use in the home and more conducive to the lifestyle of the patient. Although it is known in the prior art to provide a portable medical dispenser, such systems remain heavy and bulky, and are impractical to carry around with the patient, as that patient goes about in his/her normal routine. For the compliance and dispensing system to be effective, the patient must be in the near vicinity to hear or see the alarms. This, of course, is burdensome, since the patient will need to leave the home or frequent other parts of the home far from the device.
Finally, despite recent developments in medical dispensing devices for the home, prior art systems are further limited in that they are not capable of dispensing medication in liquid form. Regardless of complexity, it is common, if not essential, for medication regimens to include liquid medication. Thus, a system for coordinating and administering complex medical regimens in the home, provided with assurances of compliance and protection from overdosage and underdosage, would not be complete without liquid dispensing capability. It is one object of the present invention to preferably provide such a capability in a compliance, co-ordination and dispensing system.
A list of prior patents which may be of interest is provided below:
______________________________________ U.S. Pat. No. Inventor(s) Issue Date ______________________________________ 5,400,301 Rackley 03/21/95 5,392,952 Bowden 02/28/95 5,367,505 Tsuchiya et al 11/22/94 5,329,459 Kaufman et al 07/12/94 5,291,191 Moore 03/01/94 5,159,581 Agans 10/27/92 4,785,981 Rodman 11/22/88 4,462,696 Yung et al 07/31/84 4,147,021 Kondo 04/03/79 ______________________________________
It is noted that some of the above patents are directed to wristwatches that include an alarm of one type or another for, for example, reminding the wearer to take medication, noting for example, the Rackley '301 patent; and one watch which includes a vibration based alarm, noting, for example, the Tsuchiya et al '505 patent. However, there is suggested no co-ordination of such a watch with a separate medication compliance, co-ordination and dispensing system.